AccuSITE™ Needle Guide 610-2339
GUDID 00841436120029
Sterile needle guide (21ga) with (14x147cm) CIV-flex cover with Enviision saline wipe
CIVCO MEDICAL INSTRUMENTS CO., INC.
Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use| Primary Device ID | 00841436120029 |
| NIH Device Record Key | fabe5e83-22ca-47fd-97dd-d6e3e311e11f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuSITE™ Needle Guide |
| Version Model Number | 610-2339 |
| Catalog Number | 610-2339 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
Device Dimensions
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
| Width | 147 Centimeter |
| Length | 14 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436120029 [Package] Contains: 10841436120026 Package: [24 Units] In Commercial Distribution |
| GS1 | 10841436120026 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093713
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
[00841436120029]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-29 |
| Device Publish Date | 2021-01-21 |
On-Brand Devices [AccuSITE™ Needle Guide]
| 00841436120029 | Sterile needle guide (21ga) with (14x147cm) CIV-flex cover with Enviision saline wipe |
| 00841436120012 | Sterile needle guide (20ga) with (14x147cm) CIV-flex cover with Enviision saline wipe |
| 00841436120005 | Sterile needle guide (18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe |
| 00841436120128 | Sterile needle guide (21ga) with (14x147cm) CIV-flex cover with Enviision |
| 00841436120111 | Sterile needle guide (20ga) with (14x147cm) CIV-flex cover with Enviision |
| 00841436120104 | Sterile needle guide (18ga) with (14x147cm) CIV-flex cover with Enviision |
Trademark Results [AccuSITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUSITE 97384139 not registered Live/Pending |
The Prudential Insurance Company of America 2022-04-27 |
 ACCUSITE 97093370 not registered Live/Pending |
Mapzot Inc. 2021-10-26 |
 ACCUSITE 90796751 not registered Live/Pending |
TruMed Systems Incorporated 2021-06-26 |
 ACCUSITE 87847145 5641045 Live/Registered |
Perceptron, Inc. 2018-03-23 |
 ACCUSITE 78066554 not registered Dead/Abandoned |
MEDTRONIC INC. 2001-05-31 |
 ACCUSITE 74466848 2171485 Dead/Cancelled |
Matrix Pharmaceutical, Inc. 1993-12-06 |
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